Attitude of community pharmacists in Saudi Arabia towards adverse drug
reaction reporting
Saleh A. Bawazir, Ph.D.*
Chairman and Associate Professor of Clinical Pharmacy
Telephone: +966-1-467-7471
Fax:
+966-1-467-7480
E-mail:
sbawazir @ksu.edu.sa
*Department
of Clinical Pharmacy, College of Pharmacy,
King Saud University, P.O. Box 2457, Riyadh 11541, Saudi Arabia
1
Abstract
Objective: To assess the attitude and behavior of community pharmacists in Saudi
Arabia regarding the reporting of adverse drug reactions (ADR).
Method: A self-administered questionnaire was delivered to a stratified random
sample of 240 community pharmacies in Riyadh city. The questionnaire comprised
of 27 questions. The first twenty five questions covered pharmacists and pharmacy
demographics, references available and continuing education activity, general
questions aimed at establishing the extent of the respondent's knowledge about the
Saudi ADR reporting system and pharmacists' behavior. One question consisted of
twenty-seven item exploring the pharmacist's attitude to reporting and the factors that
either positively or negatively, affecting his attitude.
Results: The total response rate was 71.7% (172/240). Most of the respondents were
expatriate employees (99.4%) with the remainder Saudi pharmacy owners. Only 21
pharmacists (13.2%) were aware of the ADR reporting program in Saudi Arabia.
Ninety-seven percent of the respondents considered the reporting of ADRs to be an
integral part of their professional duties and all respondents acknowledged the
importance of reporting. Four percent of pharmacists surveyed claimed that they had
submitted ADR report to the Ministry of Health (MOH) and 6.3% of pharmacists
claimed that they submitted ADR report to the pharmaceutical company. Several
barriers identified, that prevent pharmacists from reporting ADR include, unknown
address (68%), reporting form not available (62.8%), do not know how to report
(41.7%) and uncertainty concerning causal relationship between ADR and the drug
(30.1%). Eighty four percent of respondents mentioned receiving a feedback from the
2
program would encourage them to report and 83.7% of respondents indicated that
publication of ADR bulletin will be important to stimulate reporting. In addition,
Twenty nine percent of the suggestions mentioned educating and training of the
pharmacist about the program as an important element that will improve pharmacists'
participation in reporting ADR.
Conclusion: The majority of pharmacists surveyed (86.8%) were not aware of the
ADRs reporting program in Saudi Arabia and only twenty-nine percent of
pharmacists were aware that pharmacists in Saudi Arabia could report an ADR to
MOH. The results emphasized the importance of establishing continuing efforts to
promote ADR reporting program and to overcome the barriers identified by the study.
3
Introduction
Spontaneous adverse drug reactions (ADR) reporting is considered the cornerstone of
any pharmacovigilance system. Post-marketing surveillance, especially for ADR , is
therefore a critical part of the process that decides whether the benefits of a drug
outweigh its risks.1 Most developed countries, have therefore, established formal
spontaneous reporting programs to detect serious ADR as efficiently and
inexpensively as possible.2
However, the major disadvantage is that reporting of
serious ADR rarely exceeds 10%.3
Furthermore, it is estimated that the rate of
reporting of any ADR in hospitalized patients in the United States is as low as 1 to
6%.4
To gain insight into reasons for underreporting several studies were conducted in
order to assess the attitudes of medical practitioners to their national ADR reporting
programs with the aim of identifying reasons for underreporting and to determine
what steps could be adapted to increase reporting rates.5-10 Reasons for not reporting
an ADR include physicians uncertainty as to whether the reaction was caused by the
medication, ADR considered too trivial to report, ADR is well known to report,
physicians were unaware of the need to report an ADR, physicians did not know how
to report an ADR, physicians were too busy to report an ADR, difficulty in finding
the right form and physicians considered reporting of an ADR as too bureaucratic.
In most countries, the spontaneous ADR reporting program mainly targets physicians
as the major source for reporting. However, in an attempt to increase reporting many
countries allowed hospital pharmacists, community pharmacists, nurses and even
patients to report ADR.11-14
4
Studies in various countries have examined the level of pharmacists’ attitude to ADR
reporting and have found that a number of factors affect attitude.15-20 Factors cited by
the surveyed pharmacists as deterrents for reporting ADR include, pharmacists were
unsure that the drug caused the reaction, unavailability of reporting forms,
pharmacists did not know how to report an ADR, the ADR is expected, pharmacists
did not think of reporting the ADR and fear of legal liability.
In 1998, the MOH in Saudi Arabia established postmarketing program that aims at
early detection of unexpected and serious ADR, detection of any increase in
frequency of know ADR, detection of quality defect of registered products and to
publish and disseminate reports regarding ADR. Training program was carried out
with cooperation of the United States Food and Drug Administration (FDA) in the
main regions of Saudi Arabia. The program was announced in the main hospitals and
private community pharmacies and ADR reporting form was distributed to these
institutions. In addition, Database for recording and storing ADR received was
constructed and an advisory committee was established to study and classify the ADR
reports.
The ADR program in Saudi Arabia has targeted all healthcare professionals to report
the ADRs, however the response was very limited. In order to investigate the reasons
for the impact on the program development a study will be conducted to assess the
attitude and knowledge of private community pharmacists, hospital pharmacists,
hospital physicians, primary health care centers physicians, and nurses towards ADR
5
reporting. This is the first part of the study in which the attitude and behavior of
private community pharmacists towards ADR reporting were assessed.
METHOD
In July 2004 the Health Affairs Directorate register listed 951 private community
pharmacies in Riyadh City. A stratified random sample of twenty five per cent (240
pharmacies) was randomly selected from the register. The author or a final year
pharmacy student visited each pharmacy between December 2004 and February 2005,
and invited the pharmacist on duty to participate in the study. The study was fully
explained to participating pharmacists verbally and by covering letter and they were
assured that only aggregate data would be reported. The response of the pharmacists
to the survey was either obtained at the same time or collected at a later time if the
pharmacist was busy. The survey instrument was based on the work of Grootheest
etal.20 The questionnaire was modified to make it convenient for community
pharmacists in Saudi Arabia. A pilot study was conducted in ten pharmacies to test
the validity of the survey form and to revise and finalize the questionnaire. The
questionnaire comprised of 27 questions. The first twenty five questions covered
pharmacists and pharmacy demographics, references available and continuing
education activity, general questions aimed at establishing the extent of the
respondent's knowledge about the Saudi ADR reporting system and pharmacists'
behavior. One question consisted of twenty-seven items exploring the pharmacist's
attitude to reporting and the factors that either positively or negatively affect his
attitude. These items were worded as a series of statements and the pharmacists were
asked to indicate their agreement or disagreement on a 4-point Likert scale from
‘strongly agree’ to ‘strongly disagree’. A final open-ended question invited the
6
respondents to suggest possible ways to increase pharmacists' motivation to report
ADRs.
The reliability of the instrument was assessed using Cronbach’s coefficient alpha. The
internal consistency of the instrument was 0.72 (95% CI 0.64–0.79). The data were
analysed using the Statistical Package for Social Sciences (version 13). The items
were checked for accuracy by examining unusual coding values and 10% of returned
surveys were randomly selected for hand checking by an independent person. Data
analysis consisted of descriptive statistics, including means with standard deviations,
and frequency distribution.
RESULTS
One hundred and seventy-two pharmacists completed the questionnaire, 51
pharmacists declined to participate because they are very busy or unwilling to
participate, and 17 pharmacists could not be contacted. The total number of usable
responses was 172 (71.7%). Demographic information is summarised in Table 1.
Most of the respondents were expatriate employees (99.4%) with the remainder Saudi
pharmacy owners. The majority of pharmacists were Egyptians (68.4%) and 28%
were from other Arab countries. All were male and more than half were 24 to 30
years old (mean 33.1 SD 6.3). Most pharmacists (95.3%) held a Bachelor of
Pharmacy degree. Forty percent of the pharmacists had between 6 to 10 years of
experience (mean 9.2 SD 6.3). Most pharmacists (73.1%) had worked less than five
years in their current job and 41% earn between 1 to 5 hours continuing education per
month. Forty percent of pharmacists estimated their patient contact time to be
between 10 to 50% of their working time. Middle East Drug Index, Martindale, and
British National Formulary were the most common references available in
7
pharmacies to check for adverse drug reactions and only 11.2% of pharmacies have an
internet access.
Familiarity with the reporting system
Only 21 pharmacists (13.2%) were aware of the ADRs reporting program in Saudi
Arabia. Thirty-three percent learn about the program from colleagues, 14.3% of the
pharmacists read about it and 9.5% pharmacists know about the program from MOH
officials. Twenty-nine percent of pharmacists were aware that pharmacists in Saudi
Arabia can report an ADR to MOH.
Attitude
More than 90% of pharmacists indicated that reporting of ADRs is responsibility of
physician, pharmacist and patient. Ninety-seven percent of respondents considered the
reporting of ADRs to be integral to their professional duties and all respondents
acknowledged the importance of reporting, although 11.4% indicated that they were
not motivated. Ninety-one percent of pharmacists saw reporting as an integral part of
pharmaceutical care and 72.5% said that ADR reporting was an indication of taking
patients' complaints seriously. Ninety-four percent of respondents believe that ADR
reporting will help them to gain more insight to the problems associated with side
effects. Most pharmacists (94.5%) said that they must be sure of the causality between
the drug and adverse reaction before reporting. Moreover, 78.3% of respondents felt
the need to discuss the report with the prescriber before reporting (Table 2).
Behaviour
Four percent of pharmacists surveyed claimed that they had submitted ADR report to
MOH and 6.3% of pharmacists claimed that they submitted ADR report to the
pharmaceutical company. Eighteen percent of pharmacists indicated that during last
month they have come across an ADR they wished to report to the MOH or drug
8
company. In addition, 83.7% of respondents indicated their willingness to report
ADRs caused by over-the-counter products supplied by their pharmacies (Table 2).
Ninety-nine percent of respondents recognized adverse events that are donated as
serious according to the criteria set by the Council for International Organizations of
Medical Sciences (CIOMS) as significant events to be reported.
Barriers
Several factors were reported that negatively affected pharmacists' willingness to
report (Table 3). About 68% of the respondents do not report because they do not
know the address where these reports should be sent, 62.8% of pharmacists do not
report because reporting forms are not available, 41.7% of respondents do not report
because they do not know how to report ADRs and 30.1% of respondents mentioned
uncertainty concerning causal relationship between ADR and the drug. About 41% of
pharmacists surveyed believed that all serious ADRs were already detected for a
newly marketed drug and 27.1% of pharmacists believe that one ADR report has little
impact on ADR reporting program. Twenty-seven percent of respondents described
the reporting form as too complicated to fill in and 22.1% of pharmacists think that
ADR reporting is time consuming. Insufficient clinical knowledge, fear of legal
liability claims, and lack of motivation were mentioned by 20.9%, 12.7% and 11.4%
of respondents, respectively. Less than ten percent of respondents indicated doubts
about confidentiality of information, difficulty to report that a drug had caused harm
to the patient, fear of ignorance impression and intention to publish their own report
on the adverse reaction.
Facilitating reporting
Table 4 shows results of factors that may encourage reporting of ADRs. Eighty four
percent of respondents mentioned receiving a feedback from the program and 83.7%
9
of respondents indicated that publication of ADRs bulletin will be important to
stimulate reporting. In addition, 60.7% of respondents agreed that reporting through
an internet will improve their participation and 52.9 % of respondents indicated that
making ADR reporting compulsory would motivate them to report. Only 30.9%
indicated that receiving financial compensation for reports submitted would motivate
them to report more ADRs. Around 40% of the respondents answered the open-ended
question invited them to suggest ways to facilitate and improve their participation in
ADRs reporting. A total of 21 suggestions that could encourage pharmacists to report
an ADR were described. Twenty nine percent of the suggestions mentioned educating
and training of the pharmacist about the program, 9% of the suggestions mentioned
the importance of explaining the mechanism of reporting and announcing the contact
numbers, and 8% of the suggestions mentioned ways to award the contributors. Other
suggestions include improving communication with the program, confidentiality,
availability of the reporting forms, protecting the reporter from liability, more
attention to ADRs reporting in university curriculum, educating the public and
identification of the drugs that should be monitored.
Discussion
This is the first survey, which we are aware of, to explore pharmacists’ attitude and
their self reported behavior towards ADR in private community pharmacies in Saudi
Arabia. The survey response rate was good (71.7%) and revealed that majority of
pharmacists employed in community pharmacies were male, middle-aged, Egyptians
with a bachelor degree. Reasons for these findings include the scarcity of Saudi
pharmacists, the rapid growth in the community pharmacy sector, the availability of
Egyptian pharmacists, financial incentives for expatriates, and the ability to speak
10
Arabic. The scarcity of Saudi pharmacists in community pharmacies is mainly due the
limited number of pharmacists (150-200/year) that graduate from one college of
pharmacy in Riyadh with most graduates joining the government sector because of
better salary and other fringe benefits. However, the situation is expected to change
with the establishment of three new colleges of pharmacy in 2001. The current
pharmacy law does not restrict community pharmacy ownership to pharmacists which
may have contributed to the lack of Saudi pharmacists surveyed. This situation is also
expected to change with the passing in May 2004 of a new law restricting ownership
of new community pharmacies to Saudi pharmacists or as a partner. At present, only
male pharmacists are permitted to work in community pharmacies in compliance with
several Saudi social and cultural constraints that preclude female pharmacists from
working in the retail sector. Similar figures regarding expatriate pharmacists working
in community pharmacies in Riyadh, have been reported earlier.21
Most of community pharmacists surveyed (86.8%) were not aware of the ADR
reporting program in Saudi Arabia. This finding is similar to the results reported for
Hong Kong pharmacists15 and far higher than figures reported for Holland20 (1%) and
UK22 (7%) community pharmacists who were not aware of the ADR reporting
program in their countries. These findings may indicate poor program announcement
to community pharmacists which is augmented by the fact that most expatriate
community pharmacists came from countries that have weak or no ADR reporting
programs. The findings emphasize the urgent need to educate and inform the
community pharmacists about the ADR reporting program. This effort should be
continuous since most of the community pharmacists were expatriates who work for
few years and are then replaced by new expatriate pharmacists.
11
The study shows a positive attitude of community pharmacists towards ADR
reporting. The vast majority of pharmacists (90%) regarded reporting suspected ADR
as a professional obligation and 97% of respondents considered ADR reporting an
integral part of pharmaceutical care. These results were very similar to figures
reported for community pharmacists in Holland20 and UK.18 In Saudi Arabia, outside
governmental hospitals, consumers obtain their medications from over 3200 private
sector community pharmacies. These community pharmacies can play a crucial role in
improving the quality of services they render to satisfy the needs and aspiration of
consumers, by providing high standard pharmaceutical care. Although pharmacy
practice in community pharmacies in Saudi Arabia has gained some improved
position, it has not yet gained the public trust for several reasons, including the lack of
professionalism, commercial pressure on community pharmacies, and lack of
enforcement of regulations governing pharmacy practice.23-25
Although MOH did not want to receive reports of only proven ADR, 94.5% of the
pharmacists indicated that they must be sure of the causality between the drug and
ADR. This finding is consistent with previous findings reported for pharmacists and
physicians in other countries,9,19,22 which reflect the fear of the reporter not to appear
foolish. This problem should be addressed seriously in any educational workshops to
alleviate pharmacist's anxiety and to strengthen clinical confidence in reporting ADR.
The proportion of community pharmacists (78.3%) who indicated that they need to
discuss the report with physician, although they are not required to do so, before
submitting to MOH may further reflect lack of confidence and probably fear of legal
12
consequences. Similar findings were reported by previous surveys.18,20 Consultation
with physician regarding reporting ADR by community pharmacists should not be
part of the program, since this may become a barrier for reporting and make the
pharmacists dependent on physician opinion.18
The findings of this study regarding reporting behavior indicate very low participation
(4%) in reporting ADR and pharmacists claims can not be verified. This finding is
consistent with the low percent of pharmacists who were aware of the ADR reporting
program in Saudi Arabia. Pharmacists in other countries contribute heavily to
spontaneous reporting programs. Survey reported by Grootheest etal12 revealed that
Canadian, Australian, Dutch, Japanese, Spanish and Portages community and hospital
pharmacists contribute 88.3%, 40.3%, 40.2%, 39%, 25.9%, and 23.4%, of ADR
reports received by their national programs, respectively.
These figures should
convince the programs administration in Saudi Arabia and other developing countries
of the value in investing in training pharmacists to report ADR. Another positive sign
revealed by this survey was the willingness of a large proportion of pharmacists to
report ADR caused by the over-the-counter products supplied by him and ability of
pharmacists to recognize serious ADR as donated by CIOMS.
The present study revealed major barriers preventing community pharmacists in Saudi
Arabia from reporting ADR. Some of these barriers were logistical barriers such as
unknown address of the ADRs reporting program at MOH, unavailability of the
reporting forms, reporting forms is too complicated, and do not know how to report.
Other barriers related to pharmacists understanding of the concept and appreciation of
spontaneous ADR reporting program. These include uncertainty regarding the
13
causality relationship, believe that all serious ADR are already known and that one
ADR report makes no difference, ADR reporting is time consuming, lack of clinical
knowledge, and fear of legal liability. Logistical barriers can be solved through proper
management and advertising of the program. Other type of barriers will require an
intensive training and workshops about the concept of spontaneous ADR reporting
and the structure of ADR reporting in Saudi Arabia. Similar findings were reported
for physicians and pharmacists in other countries7,10,15,16.
To facilitate pharmacist's participation in ADR reporting, 84% of respondents
mentioned, receiving a feedback as an important factor. This point should be taken
seriously by the program and a customized feedback report should be sent to the
pharmacist who submits an ADR report. This way the sender of the report is both
informed that his or her report has been taken account of and receives information
about the evaluation the experts of the program have made26. This finding was similar
to results reported for community Dutch pharmacists20. The second important factor
mentioned that will facilitate reporting of ADR is publication of ADR bulletin that
would inform pharmacists about the program on regular basis. In addition, the general
comments of the respondents suggested the importance of educating and training the
pharmacists about ADR reporting. Previous surveys also mentioned education and
training as important motivation factors16,22. Reporting through the online internet
may facilitate reporting according to some respondents. The online internet is an
important logistic, that should be utilized to the maximum by the program. All aspect
of the ADR reporting program should be placed in the internet and health care
professional should by informed and encouraged to use it. About one third of the
pharmacists mentioned, receiving a fee for report submitted, which is similar to
14
results reported for the UK pharmacists22, and higher than the 18% mentioned by
Dutch pharmacists20. These results may indicate that financial compensation is not an
important factor that will encourage pharmacists to report an ADR. This is because
ADR reporting is perceived as an inherited pharmacist professional activity.
Moreover, the respondents were divided to whether the ADR reporting should
become a mandatory activity. Earlier studies revealed that physicians fail to report
ADRs for several reasons and neither financial incentives nor compulsory legislation
seems to be the solution.27
In conclusion, the majority of community pharmacists surveyed were not aware of the
ADR reporting program in Saudi Arabia. Several approaches should be adopted by
Saudi regulatory authority to stimulate pharmacists' participation in ADR reporting
program. Broadly, these may include establishing formal access to the ADR reporting
program, educational efforts directed to community pharmacists about the reporting
system, facilitating the process of reporting by making reporting forms easy to
complete and widely available (paper or electronic), and improved feedback to
reporters.
Acknowledgement
I would like to thank Dr Ronald Meyboom and Dr Sayed Refat for reviewing the
manuscript and for their valuable comments and suggestions.
15
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17
Table 1. Demographic information of private community pharmacists (n=172)
Variable
Sex
Male
Female
Number **(%)
172 (100)
0
Age in Years
24-30
31-40
>40
Mean ± SD
60 (53.6%)
40 (35.7%)
12 (10.7%)
33.1 ± 6.3
Education
Bachelor
Master
163 (95.3%)
8 (4.7%)
Pharmacist Experience in years
1-5
6-10
>10
Mean ± SD
47 (31.8%)
59 (39.9%)
42 (28.4%)
9.2 ± 6.3
Duration at work in years
<3
3-5
>5
Mean ± SD
67 (39.2%)
58 (33.9%)
46 (26.9%)
4.6 ± 4.0
Nationality
Egyptian
Syrian
Sudanese
Indian
Others
117 (68.4%)
15 (8.8%)
10 (5.8%)
5 (2.9%)
24 (14.1%)
Patient contact time
<10%
10-50%
>50%
Can not specify
22 (13.6%)
66 (40.7%)
30 (18.5%)
44 (27.2)
Continuing education hours per month
None
1-5 hours
6-10 hours
>10 hours
48 (28.9%)
68 (41.0%)
32 (19.3%)
17 (10.8%)
References available
Middle East Drug Index
Martindale
British National Formulary (BNF)
Saudi National Formulary (SNF)
MIMS
None
91 (53.8%)
56 (33.3%)
56 (33.3%)
42 (24.8%)
35 (20.7%)
3 (1.7%)
** Not all respondents completed all questions
18
Table 2: Attitude and behaviour towards ADR reporting (n=172)
Statements
Level of agreement (percentage)
Strongly
Agree
Agree
Disagree
Strongly
Disagree
54.4
42.6
3.0
0
65.5
34.5
0
0
45.1
49.4
5.5
0
1.9
14.5
54.1
29.6
a. hospitalization
62.0
36.0
2.0
0
b. a life threatening situation
71.0
29.0
0
0
c. a congenital anomaly
d. persistent disability or
incapacity
e. death of the patient
6. I report to get more insight into ADR
questions that I come across in my practice
7. I report to show the patient that their
concern is being taken seriously.
8. I always report ADRs because it is part
of pharmaceutical care.
9. Consulting the physician is important
before reporting an ADR
10. ADRs reporting should compulsory
71.8
66.7
28.2
32.7
0
0.6
0
0
74.2
39.5
25.2
54.8
0.6
4.5
0
1.3
19.9
52.6
22.4
5.1
34.0
56.9
8.5
0.7
26.7
51.6
18.0
3.7
16.7
44.2
32.1
7.1
11. ADRs reporting should be voluntary
10.7
38.7
39.3
11.3
1. Reporting ADRs is part of the
professional role of a pharmacist.
2. I believe that the science of monitoring
drug safety (pharmacovigilance) is
important
3. I want to be sure the ADR is related to
the drug before reporting
4. I do not report ADRs of OTC products
supplied by my pharmacy
5. I report an ADR that causes:
19
Table 3: Barriers to ADR reporting (n=172)
Barriers
Level of agreement (percentage)
Agree
Disagree
1. No reporting forms available.
Strongly
Agree
18.3
44.5
32.9
Strongly
Disagree
4.3
2. Reporting address unknown
16.1
51.6
29.2
3.1
3. Reporting form too complicated
2.7
24.2
64.4
8.7
4. Reporting ADRs is time consuming.
3.9
18.2
61.7
16.2
5. All ADRs are known
8.8
32.0
52.4
6.8
6. Want to publish myself.
0.7
3.9
71.2
24.2
7. Confidentiality.
2.0
7.2
71.2
19.6
8. Patient confidence
9. Difficult to admit harm to patient
10. Reporting could show ignorance
1.3
0.6
1.3
7.1
8.4
7.6
74.4
75.3
72.8
17.3
15.6
18.4
11. Fear of liability
12. No motivation
13. Insufficient clinical knowledge.
14. Do not know how to report
1.3
0.6
1.3
7.1
11.4
10.8
19.6
34.6
68.4
70.1
57.6
48.1
19.0
18.5
21.5
10.3
15. Causality uncertain
16. One report make no difference
1.3
3.9
28.8
23.2
56.9
61.9
13.1
11
20
Table 4 : Factors encouraging pharmacist to report an ADRs (n=172)
Factors
Level of agreement (percentage)
Agree
Disagree
1. An obligation to do so.
Strongly
Agree
9.0
43.9
38.1
Strongly
Disagree
9.0
2. there was a fee
5.9
25.0
49.3
19.7
3. Saw colleagues doing so.
6.8
38.5
44.6
10.1
4. Attention drawn by a publication,
18.8
64.9
11.7
4.5
5. Receiving feedback
19.9
64.2
13.2
2.6
6. Report through the Internet
15.2
45.5
33.1
6.2
21